The revised models for February 2018 of the Clinical Trial Agreement (mCTA) and the Clinical Research Organisation model Clinical Trial Agreement (CRO-mCTA) are designed to be used without modification for industry-sponsored studies of patients with NHS/HSC in hospitals across the UK health service. The organisational information document is a key component of the UK Local Information Pack for commercial and non-commercial research projects. It replaces activity declarations used for non-commercial studies in England and Wales; and the NHS/HSC Site Specific Information (SSI) form in Scotland and Northern Ireland. See www.myresearchproject.org.uk/help/hlpsitespecific.aspx#UK-Local-Information-Pack-OID The model of the Clinical Trial Agreement for Biopharmaceutical Research in the Primary Care Industry (Primary Care mCTA) has been developed and approved by the British Pharmaceutical Industry Association, the BioIndustry Association, a number of highly active general practitioners, the British Medical Association, the Medical Protection Society and the UK Health Boards. The Health Research Authority (HRA) supports the application of standard agreements. The NHS and HSC NSCs should be established through a subcontracting agreement with participating NHS and HSC organizations. Appropriate data processing agreements should be concluded using the appropriate agreement model: the Triapartt agreement is intended to be used when the management of a commercial clinical trial is outsourced by the sponsor to a contract research organization. CRO mCIA is supported by the UK Health Services, the National Institute for Health Research, the Association of British Healthcare Industries, the NHS Confederation, the Medical Schools Council, the UK Clinical Research Collaboration, the NHS Research Forum and the Institute for Clinical Research. These model agreements apply to health services in England, Northern Ireland, Scotland and Wales; they replace the 2011 country versions. The accompanying guidelines provide more general information, an overview of changes from the 2011 versions, and additional information on how models should be used and under what circumstances.
MICRA was developed by a working group led by the NIHR Office for Clinical Research Infrastructure (NOCRI) and the Medical Research Council. Representatives from industry, universities, the NHS and the Intellectual Property Office worked with legal opinions to develop a model agreement that could support all collaborative research scenarios. Organizations participating in the working group agreed on a statement of support in which they encouraged their use to streamline the collaborative research allocation process. The non-commercial research model (MNCA) is a model for documenting the relationship between non-commercial sponsors of a research study and the organization of the health service in which the study and responsibility of non-commercial sponsors takes place. Please note that UoA R-I must be involved in the development of mNCA for all studies. Please read: www.hra.nhs.uk/about-us/news-updates/new-version-uk-wide-model-non-commercial-agreement-mnca-published/ The workshop is free and is open to representatives of non-commercial organizations (NHS, CTU, HEI, Research Charities, etc.) and participating NHS organizations responsible for the development and/or verification of non-commercial implementation agreements.